Identity
- Trade Name
- Quantib AI Node FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Model / Reference
- 2.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719689791100 FDA UDI
- 510(k) Number
- K200899 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
Quantib AI Node by Quantib B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology DICOM image processing application software.
- Imbio Freya — Imbio, LLC · Class II
- Pacs View — BRIT SYSTEMS · Class II
- XR90 System, LOGIQ, Upgrade Kit — MediView XR · Class II
- OptiVu™ Mixed Reality — Orthosoft Inc · Class II
- PowerLook PRO+ Rack-Mount, OUS — Icad, Inc. · Class I
- Annalise Triage — Annalise-Ai Pty , Ltd. · Class II
- PowerLook PRO+ 4GPU Tower Platform, US — Icad, Inc. · Class I
- PowerLook PRO+ 4GPU Tower Platform, OUS — Icad, Inc. · Class I
Cleared under the same submission
K200899 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quantib B.V.
Sources (1)
- FDA UDI 803c0054-18aa-4dd0-be9d-fc1a1597b7ec 33 fields · synced Jun 1, 2026